Provides An Update On Its NATiV3 Clinical Program Evaluating Lanifibranor In Patients With MASH/NASH
- Recruitment in NATiV3 clinical trial continues in both cohorts with over 80% of the targeted number of patients enrolled in the main cohort and 100% in the exploratory cohort of NATiV3.
- Analysis of the baseline characteristics of all patients randomized in the main cohort of NATiV3 show a patient profile similar to patients randomized in the NATIVE Phase IIb clinical trial.
- A blinded analysis of all randomized patients suggests weight gain plateaus and stabilizes between week 24 and 36.
- First visit of the last patient of NATiV3 is anticipated to occur during the second half of 2024, and topline results are expected at the beginning of the second half of 2026.
- Patent portfolio strengthened with new patent secured protecting the compound until 2043.
- The Company is currently working on multiple fronts to secure financing to fund the continuity of its activities.
Daix (France), Long Island City (New York, United States), July 5, 2024 – Inventiva (NASDAQ:IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other diseases with significant unmet medical needs, today provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position.
The recruitment in NATiV3 is advancing with screening ongoing at 347 sites across 19 countries. As of July 5, 2024, 1,027 patients have been randomized of which 784 patients in the main cohort of NATiV3, representing 82% of the targeted number. The geographical distribution of the main cohort confirms that North America and Western Europe are the key contributors to patient recruitment (67% and 21% respectively) while China has only contributed marginally (2% of patients). The targeted number of 200 patients to be recruited in the exploratory cohort has been met with 243 patients randomized to date. The recruitment in the exploratory will continue until recruitment is complete in the main cohort.